Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients

• Conditions: Ards

• Registration Number: NCT03763890
• Lead Sponsor: Southeast University, China

Brief Summary

This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Detailed Description

ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age≥18 or<80；
2. Moderate or sever ARDS in 2012 <Berlin definition>;
3. Applied mechanical ventilation;
4. Consent signed.

Exclusion Criteria

1. Asthma or COPD；
2. Cardiogenic edema；
3. Sever neutropenia(<500/mm3)；
4. Hemodynamic astatic: DOPA or Dobutamine >15 µg/kg/ min; NE > 15ug /min；
5. GCS coma score ≤12；
6. Thoracic injury or surgery patients contradict EIT ；
7. Refuse to join in trail；
8. Included in other clinical trail。

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plateau pressure	September,1,2018-December 30, 2020	The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.
Trans-pulmonary pressure	September,1,2018-December 30, 2020	The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress
PaO2	September,1,2018-December 30, 2020	The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)
PaCO2	September,1,2018-December 30, 2020	The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .
respiratory rate	September,1,2018-December 30, 2020	The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.
peak pressure	September,1,2018-December 30, 2020	The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..
flow	September,1,2018-December 30, 2020	The researchers record the set Flow (L/min) in patients with mechanical ventilation.
alveolar hyper-distention; alveolar collapse；alveolar opening and closing；	September,1,2018-December 30, 2020	The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).
EELV	September,1,2018-December 30, 2020	The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain
tidal volume	September,1,2018-December 30, 2020	The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..
FiO2	September,1,2018-December 30, 2020	The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
DBP	September,1,2018-December 30, 2020	Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
CVP	September,1,2018-December 30, 2020	Recording CVP(central venous Pressure）,which is always discontinuously monitored with jugular pressure monitor mmHg).
SBP	September,1,2018-December 30, 2020	Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
vasopressor	September,1,2018-December 30, 2020	Recording clinical vasopressor usage including Norepinephrine（ μg/Kg/min;）Epinephrine（μg/Kg/min） Dobutamine （ μg/Kg/min)

Trial Locations

Locations (1)

Nanjing Zhong-Da Hospital; 🇨🇳 Nanjing, Jiangsu, China